FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines

The FDA has approved and authorized updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna to address currently circulating variants. The updated mRNA vaccines, which now include a monovalent component designed to correspond to Omicron variant XBB.1.5, are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age. With these actions, the FDA announced the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized in the United States.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

The FDA published the following information about the vaccines:

• Individuals 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least 2 months since the last dose of any COVID-19 vaccine.
• Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
• Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated authorized Moderna COVID-19 Vaccine.
• The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.
• Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets.
• The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.

Vaccine Manufacturers Weigh-in

Both vaccine manufacturers (Moderna and Pfizer-BioNTech) have publicly announced that the updated vaccines would be ready this fall.

"COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season. As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season," Moderna CEO Stéphane Bancel, said in statement. "We appreciate the FDA's timely review and encourage individuals who intend to get their flu shot to also get their updated COVID-19 vaccine at the same time."

“This decision comes at a time when COVID-19 cases are once again climbing. Now, most people 6 months or older in the US are eligible to receive this season’s COVID-19 vaccine, even if they have never been vaccinated against COVID-19 before,” Pfizer CEO Albert Bourla, said in a statement. “We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities, so people can ask their doctor about receiving their COVID-19 vaccine during the same appointment as their annual flu shot, saving time now and helping to prevent severe disease later when respiratory viruses are at their peak.”

The CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting tomorrow to discuss recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromised and older individuals.